Host-microbiota Interactions in Auto-inflammatory Diseases (HO-MICRO-MAI)
17. juli 2026 opdateret af: Assistance Publique - Hôpitaux de Paris
Autoinflammatory diseases (AID) are genetic diseases responsible for excessive activation of innate immunity leading to blood inflammation and systemic symptoms.
Most patients display digestive involvements that may resemble inflammatory bowel disease.
Several studies have found dysbiosis in some AID.
Gut microbiota can communicate with the host via gut-derived metabolites (Fatty acids, tryptophan, bile acids) that may have either pro-inflammatory or anti-inflammatory effects.
Some metabolites can also activate the Aryl hydrocarbon receptor (AhR) pathway, which enhances gut barrier.
Gut barrier dysfunction has already been associated with AID.
Therfore, dysbiosis could promote digestive and inflammatory involvements in genetically predisposed patients via perturbations of gut-derived metabolites.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
Patients will receive oral and written information about the research during a routine consultation.
A 10mL urine tube will be collected for research. A stool collection kit including a self-questionnaire to be filled out on the day of the stool collection will be given to all included patients to be collected on site or at home within three months after inclusion and to be returned to the laboratory by mail using a pre-stamped envelope provided at the time of inclusion and a self-questionnaire to be filled out on the day of the stool collection Blood and urine samples will be brought by an accredited carrier to the laboratory "Microbiota, Intestine and Inflammation"; UMRS-938 Sorbonne University, Hôpital Saint-Antoine where they will be analyzed. Stool samples will be sent by mail for stool samples.
If blood sampling is planned as part of routine care, 3 additional tubes (15mL, one dry tube of 5mL, 2 EDTA tubes of 5mL each) of peripheral blood will be collected.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sophie GEOGIN-LAVIALLE, MD PhD
- Telefonnummer: +33 01 56 01 70 82
- E-mail: sophie.georgin-lavialle@aphp.fr
Undersøgelse Kontakt Backup
- Navn: Inès ELHANI, MD
- Telefonnummer: +33 01 56 01 70 82
- E-mail: ines.elhani@aphp.fr
Studiesteder
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-
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Paris, Frankrig, 75020
- Rekruttering
- Internal medicine, Tenon Hospital (APHP)
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Kontakt:
- Inès ELHANI, MD
- Telefonnummer: +33 01 56 01 70 82
- E-mail: ines.elhani@aphp.fr
-
Kontakt:
- Sophie GEORGIN-LAVIALLE, MD, PhD
- Telefonnummer: +33 01 56 01 70 82
- E-mail: sophie.georgin-lavialle@aphp.fr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with auto-inflammatory diseases (Familial Mediterranean Fever, Mevalonate kinase deficiency, Cryopyrin-associated periodic fever, A20 haploinsufficiency, ADA2 deficiency, LACC1-associated juvenile arthritis, JAK1-associated autoinflammatory disease, or Syndrome of Undifferentiated Recurrent Fever ) followed up in the French reference center of autoinflammatory diseases.
Beskrivelse
Inclusion Criteria:
- Patients with autoinflammatory diseases aged >12 years and followed in the CEREMAIA internal medicine department present for consultation or day hospital for a routine care visit.
- FMF defined by the Eurofever/PRINTO criteria
- or CAPS définie by the Eurofever/PRINTO criteria
- or MKD defined by the Eurofever/PRINTO criteria
- or - DADA2 defined by the presence of two mutations in the ADA2 gene with pathogenicity of at least ≥ 3
- or - HA20 defined by the presence of one TNFAIP3 mutation with pathogenicity of at least ≥ 3
- or - JAAD defined by the presence of one JAK1 mutation with pathogenicity of at least ≥ 3
- or Juvenile polyarthritis defined by the presence of one LACC1 mutation with pathogenicity of at least ≥ 3
or - Unclassified AMI defined by:
- Fever +/- systemic symptoms Recurrent
- Biological inflammation (CRP>20mg/l) in crisis or permanent
- Absence of pathogenic mutation highlighted by current next-generation sequencing techniques in known autoinflammatory disease genes
- Collection of non-opposition to participation in research and specific consent for the biological collection of the patient or their legal representative in the case of a minor patient
- Lack of legal protection
- Patients benefiting from a social security scheme
Exclusion Criteria:
- Antibiotic therapy within 3 months prior to inclusion. If antibiotic therapy was initiated between inclusion and stool collection (data collected on the self-administered questionnaire accompanying the stool collection), the analysis data performed prior to antibiotic therapy will be retained, and the stool will not be analyzed.
- Current infection on the day of inclusion
- No social security
- Refusal to participate
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Patients with autoinflammatory diseases
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Stool and blood Gut-derived metabolites in patients with AID
Tidsramme: 3 months
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Quantification of gut-derived metabolites in stools using mass spectrometry
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3 months
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Stool and blood Gut-derived metabolites in patients with AID
Tidsramme: 3 months
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Qualitative evaluation of gut-derived metabolites in stools
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3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Role of AhR on activation of inflammatory pathways
Tidsramme: during the inclusion visit, baseline, day 1
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Quantification of pro-inflammatory cytokines in presence of AhR agonists on patients' monocytes
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during the inclusion visit, baseline, day 1
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Microbiota in AID patients
Tidsramme: 3 months
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Dysbiosis measured by alpha and betadiversity
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3 months
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Effect of gut-derived metabolites on inflammatory pathways though cytokine production
Tidsramme: 3 months
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Increase or decrease in proinflammatory cytokines secreted
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3 months
|
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Association of microbiota profile with biological control of the disease
Tidsramme: 3 months
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Correlation between microbiota profiles and inflammation biomarkers (C-reactive protein, Serum A Amyloid, proteinuria)
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3 months
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Association of microbiota profile and severity of the disease
Tidsramme: 3 months
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Correlation between microbiota profiles and complications (AA Amyloidosis, Cirrhosis)
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3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Sophie GEORGIN-LAVIALLE, APHP
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. marts 2026
Primær færdiggørelse (Anslået)
1. september 2026
Studieafslutning (Anslået)
1. september 2029
Datoer for studieregistrering
Først indsendt
20. april 2026
Først indsendt, der opfyldte QC-kriterier
17. juli 2026
Først opslået (Faktiske)
22. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- APHP230035
- IDRCB 2025-A01478-41 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
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